Device for analyzing a sample

ABSTRACT

A suction generating device for a sample analysis device is provided. The device comprises four parts, namely, a cover plate  61 , a middle plate  62 , a bottom plate  63  and an operation plate  64 . A protruding portion  642  for compressing the suction generating chamber is formed in an approximately center portion on the lower side of the operation plate  64 , a protruding portion  641  for operation is formed in an approximately center portion on the upper side of the operation plate  64 . A cavity  631  for inserting the sample analysis device therein is formed in an approximately center portion in the bottom plate  63 ; and a hole  632  for light irradiation is punched in a determined portion in the cavity  631 . A concave portion  623  for fitting the operation plate  64  therein is formed in the middle plate  62 , and a window section  621  is formed in the center of the concave portion  623  to let the lower protruding portion  642  on the operation plate  64  protrude therethrough. A window section  611  is formed in the cover plate  61  to let the upper protruding portion  641  on the operation plate  64  protrude therethrough.

This application is a continuation of application Ser. No. 09/255,253,filed Feb. 22, 1999, now U.S. Pat. No. 6,180,062 which is a continuationof Ser. No. 08/847,745, filed Apr. 22, 1997, now U.S. Pat. No.6,001,307, Published on Dec. 14, 1999 which application(s) areincorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates to a suction generating device fordeveloping suction in a sample analysis device, in which the suction isutilized for forced-sucking.

BACKGROUND OF THE INVENTION

There are various types of samples in the field of analytical chemistry,and particularly in the medical field, body fluids such as blood, urine,spinal fluid, saliva, and the like, are important subjects for analysis.A need has arisen for analyzing such samples in large amounts andcollectively.

In order to meet this need, a sample analysis device, having a reagentfilm previously impregnated with a reagent and stuck on a strip, hasbeen developed and used. In such a device, the reagent film is suppliedwith a sample such as blood, and the sample is allowed to react with thereagent to generate a pigment, which develops a color in the reagentfilm, and then the degree of the color is analyzed by an opticalmeasuring apparatus such as a densitometer. By using this device,operations for preparing a reagent and allowing the reagent to reactwith the sample can be simplified, so that the whole analysis operationcan be converted into a routine exercise.

In such a sample analysis device, examples of methods for supplying thereagent film with a sample include a method utilizing capillarity,spotting, dipping, and the like. Among these methods, methods utilizingcapillarity have been most commonly used. Because it is required tointercept external light during optical measuring, the sample supplyingportion and the analysis section must be positioned at a considerabledistance from one another when the device is set in an optical measuringapparatus. Therefore, the sample must be moved in the device,capillarity being used as the means for moving the sample. Examples ofdevices utilizing capillarity are disclosed in Japanese PublishedUnexamined Patent Application No. Hei 4-188065 and Japanese PublishedUnexamined Patent Application No. Sho 57-132900.

FIG. 10 shows one example of a sample analysis device utilizingcapillarity. As shown in the drawing, the device has a triangular shapedsampling point 42 protruding from an approximately center portion of thefront face 44 of a transparent base member 47 made of acrylic resin, agroove 46 extending from the sampling point 42 toward the back portionof the base member 47, and a slot 45 formed as an extension of thegroove. Furthermore, a reagent film 48 is stuck on the upper face of thebase member 47 on the side of the front face 44 so that it may cover thegroove 46. The structure of the reagent film 48 is determined asappropriate depending on the type of the sample. For example, whenanalyzing plasma components of blood, the reagent film used comprises afiltration layer, a reagent layer, a transparent protective layer, andan opaque protective layer, which are laminated in this order from thebottom, and in which an observation window 50 for entering light isformed in an approximately center portion in the opaque protectivelayer.

Analysis using this device may be carried out as in the following steps.First, a drop of blood is obtained from a subject and brought intocontact with the sampling point 42. Then, the blood is drawn into thegroove 46 by capillarity and the whole groove is filled with the blood.When the blood permeates into the reagent film 48 covering the upperportion of the groove 46, first erythrocytes are removed by thefiltration layer, and plasma components reach the reagent layer and areallowed to react with the reagent to generate a pigment, which developsa color in the reagent layer. In this state, the device is set in anoptical measuring apparatus such as a densitometer, where the degree ofthe color developed in the reagent layer is measured by irradiatinglight through the observation window 50.

However, in using a device utilizing capillarity, there are problems asdescribed below.

First, because a capillary channel needs to be continuously filled witha sample in order to cause capillarity, the sample must be provided in alarger amount than is required in analysis. In addition, because ittakes some time to introduce the sample by capillarity, measuring cannotbe carried out quickly. Furthermore, in body fluids such as blood, thereare individual differences in properties such as viscosity, which affectcapillarity, so that time required for introducing the sample into theanalysis section or the like cannot be fixed. As a result, the timerequired for analysis, including the time for reaction with a reagent,is difficult to be fixed, and also an error might be caused in theanalysis results. Furthermore, since the drawing force by capillarity isvery weak, it is easily affected by gravity. Therefore, when introducinga sample, the inclination of the device has to be restricted, and alsothe structure of the optical measuring apparatus used is limited.Furthermore, the sample supplying portion and the analysis sectioncannot be positioned at a distance from each other because of theweakness of the drawing force by capillarity, therefore, in an opticalmeasuring apparatus, possibilities of contamination of the measuringapparatus during introduction of a sample, or influence of externallight, cannot be completely eliminated.

On the other hand, the spotting method for supplying samples has thedisadvantage in that, when using blood as the sample, the sampling spotis limited to a fingertip, and sampling from an ear or the abdomen isdifficult to perform.

SUMMARY OF THE INVENTION

It is an object of the present invention to provide a suction generatingdevice for developing suction in a sample analysis device, whichutilizes the suction to achieve rapid and precise analysis of a smallamount of sample.

Viewed from a first aspect, the present invention provides a firstsuction generating device for developing suction in a suction generatingchamber in a sample analysis device, said sample analysis devicecomprising a suction generating chamber having elasticity, a drawingchannel in communication with the suction generating chamber, ananalysis section formed in a certain position in the drawing channel,and a suction opening formed at the end of the drawing channel, saidsuction generating device comprising a compressor for compressing thesuction generating chamber and a releaser for releasing the chamber fromcompression.

Previously, the applicant has separately filed applications forinventions related to a sample analysis device utilizing forced suction(Japanese Patent Application No. Hei 8-107310, Japanese PatentApplication No. Hei 8-236131, and Japanese Patent Application No. Hei9-102204). By using these devices, a small amount of sample can beanalyzed rapidly and precisely. The applicant has developed the suctiongenerating device of the present invention in order to improve theoperational performance of a forced suction type sample analysis device,and further expand the range of its application. In a general method ofusing the sample analysis device, first, a sample needs to be drawn intothe sample analysis device by suction developed by a manual operation,and then the device is set in a testing machine, so that complexoperation is often required. Therefore, the present invention achievesautomation for generating suction by providing a device comprising acompressor for compressing the suction generating chamber and a releasorfor releasing the chamber from the compression. That is, the suctiongenerating chamber is automatically compressed simply by setting thesample analysis device in the device of the present invention.Therefore, if the device of the present invention is installed in atesting apparatus or the like, the analysis operation can be simplified.

In a preferred embodiment of the present invention, the suctiongenerating device further comprises a cavity into which is inserted asample analysis device and which holds said sample analysis devicetherein, and a protruding portion capable of compressing the suctiongenerating chamber as the sample analysis device is inserted into thecavity, the protruding portion being movable, such that the suctiongenerating chamber can be released from compression by moving theprotruding portion.

In this embodiment, when the sample analysis device is inserted into thecavity, the suction generating chamber is automatically compressed bythe protruding portion. In this state, the suction opening of the sampleanalysis device is brought into contact with a sample such as blood, andthereafter, by moving the protruding portion, the suction generatingchamber is released from compression, and suction is developed as thechamber returns to its original shape. This suction transfers the sampleinto the analysis section of the device. Then, the sample is analyzed byan optical means such as densitometry.

In an alternative embodiment of the invention, the suction generatingdevice is applied for developing suction in a sample analysis device, inwhich an air vent hole is formed in a suction generating chamber. Theprocess for inserting the sample analysis device into the suctiongenerating device includes two stages. This suction generating devicefurther comprises a first protruding portion capable of compressing thesuction generating chamber in a first stage of insertion, and a secondprotruding portion capable of dosing the air vent hole in the suctiongenerating chamber in a second stage of insertion, during which thesample analysis device is inserted deeper into the cavity so that thesuction generating chamber is released from compression.

As stated above, this suction generating device is used with a sampleanalysis device having an air vent hole formed in the suction generatingchamber. This device is used, for example, in the following process.First, a sample is brought into contact with the suction opening of thesample analysis device and is held in a portion near the opening in thedrawing channel by capillarity. Then, in a first stage, the sampleanalysis device is inserted into the cavity of the suction generatingdevice so that the suction generating chamber is compressed by the firstprotruding portion. During this compression, the air contained in thesuction generating chamber is discharged through the air vent hole, sothat the sample held in the portion near the opening in the drawingchannel cannot be pushed out. Then, in a second stage, the sampleanalysis device is inserted deeper into the cavity so that the chamberis released from the compression by the first protruding portion, whilethe air vent hole is closed with the second protruding portion. As aresult, suction is developed as the suction generating chamber returnsto its original shape, thereby transferring the sample into the analysissection. Then, as mentioned above, the sample is analyzed by an opticalmeans or the like.

By using the above device, a sample can be moved simply by inserting thesample analysis device into the suction generating device, so thatoperation of sampling is simplified. Furthermore, the operation ofholding the sample in a portion near the opening in the drawing channelin the sample analysis device may be performed after the analysis devicehas been inserted in the suction generating device in the first stage.

Furthermore, in the above-mentioned device, the two-stage insertion canbe carried out in one step, that is, the sample is continuouslytransferred into the analysis section in one inserting operation.

The present invention also provides a further device for developingsuction in the suction generating tube in a sample analysis device,which sample analysis device comprises a suction generating tube havingelasticity, a drawing channel in communication with the suctiongenerating tube, an analysis section formed in a certain position in thedrawing channel, and a suction opening formed at the end of the drawingchannel, one end of the suction generating tube being open and the otherend communicating with the drawing channel, and the suction generatingtube being arranged in such a manner that its open end is turned towardthe end of the sample analysis device having the suction opening. Thisfurther device comprises a cavity into which is inserted the sampleanalysis device and which holds the sample analysis device therein, anda protruding portion provided at a certain position inside the cavitywhich is capable of sequentially deforming the suction generating tubeto generate suction as the sample analysis device is inserted into thecavity.

The device is for use with a sample analysis device having a suctiongenerating tube as a means for developing suction. The suctiongenerating tube develops suction as it is sequentially deformed. Thedevice is used, for example, as follows: First, the suction opening inthe sample analysis device is brought into contact with a sample whichis held in a portion near the opening in the drawing channel bycapillarity. Then, the suction generating tube is sequentially deformedby the protruding portion to develop suction as the sample analysisdevice is inserted into the cavity, thereby transferring the sample intothe analysis section. Then, the sample is analyzed by an optical meansor the like.

The present invention also provides a sample analysis apparatuscomprising a suction generating device in accordance with the presentinvention and a means for analyzing a sample. This sample analysisapparatus may comprise conventionally known components of the inventionin addition to the suction generating device of the invention. Examplesof means for analyzing a sample include an optical analysis meanscomprising a light irradiating section and a light detecting section, anelectrical analysis means comprising an electric signal generating meansand an electric signal detecting means, or the like. These means can bealso any conventionally known means.

BRIEF DECSRIPTION OF THE DRAWINGS

Some preferred embodiments of the invention will now be described by wayof example only and with reference to the accompanying drawings inwhich:

FIG. 1 (A) is a plan view of one example of a sample analysis device,and FIG. 1 (B) shows a cross-sectional view taken along the line III—IIIof FIG. 1 (A);

FIG. 2 is an exploded perspective view of the sample analysis device ofFIG. 1;

FIG. 3 is an exploded perspective view of one embodiment of a suctiongenerating device according to the present invention;

FIG. 4 (A) is a plan view of the suction generating device of FIG. 3,and FIG. 4 (B) is a cross-sectional view taken along the line I—I ofFIG. 4 (A);

FIG. 5 (A) is a plan view of a sample analysis device in a condition inwhich a sample is held in the liquid pooling portion in the device, andFIG. 5(B) is a plan view of the device in a condition in which thesample is moved into the analysis section;

FIG. 6 is a cross-sectional view of another example of a sample analysisdevice;

FIGS. 7(A)–7(D) are cross-sectional views showing another embodiment ofa suction generating device of the present invention and its method ofuse;

FIG. 8 is a cross-sectional view of still another example of a sampleanalysis device;

FIGS. 9(A)–9(D) are cross-sectional views showing still anotherembodiment of the suction generating device of the present invention andits method of use; and

FIG. 10 is a perspective view of a conventional sample analysis device.

PREFERRED EMBODIMENTS OF THE INVENTION EXAMPLE 1

Firstly, FIG. 1 shows an example of a sample analysis device usable withthe first and second embodiments of suction generating devices of thepresent invention. FIG. 1 (A) is a plan view of the sample analysisdevice, and FIG. 1 (B) is a cross-sectional view taken along the lineIII—III of FIG. 1 (A). As shown in the drawings, the sample analysisdevice is formed by laminating a plurality of films, and the body isapproximately rectangular plate shaped.

In this sample analysis device, a suction generating chamber 1 is formedas a protrusion in an end side portion of the approximately rectangularplate shaped body (right side in the drawing), and a drawing channel 2extends from a position below the suction generating chamber 1 towardthe end (the other end) opposite to the suction generating chamber 1 inthe approximately rectangular plate shaped body. An analysis section 3is formed in a certain position in the drawing channel 2, and the end ofthe drawing channel 2 communicates with a suction opening 4 formed atthe other end of the approximately rectangular plate shaped body througha liquid pooling portion 9. A window 10 is formed under the analysissection 3. The window 10 may be formed as needed. For example, whenglucose oxidase (GOD) is used as a reagent, because this reagentrequires oxygen for color development, a window should be formed forsupplying oxygen. However, except in such a case, if the portion of thefilm corresponding to the analysis section 3 is transparent so thatlight may be admitted into the analysis section 3, such a window is notrequired. Furthermore, a reagent film 7 impregnated with a reagent isplaced below the analysis section 3 in such a manner so that it coversthe window 10. Furthermore, a gas-permeable liquid-impermeable stopper 8is formed in a certain position between the suction generating chamber 1and the analysis section 3 in that part 2 b of the drawing channel 2 onthe side of the suction generating chamber 1. The gas-permeableliquid-impermeable stopper 8 is formed by placing a hydrophobic porousfilm in a given position in the drawing channel 2 b.

Furthermore, an air vent passage 25 branches from a certain positionbetween the liquid pooling section 9 and the analysis section 3 in thesection 2 a of the drawing channel 2, and its end 26 opens to theoutside of the body. Thus, as its ends are both open, the air ventpassage 25 develops capillarity.

Furthermore, the size of the cross section of the air vent passage 25 issmaller than that of the passage of the liquid pooling portion 9, thusliquid flow resistance in the air vent passage 25 is larger than in theliquid pooling portion 9. In particular, the width of the liquid poolingportion 9 is about four times those of the drawing channel 2 and the airvent passage 25, and the thickness of the liquid pooling portion 9 isabout twice those of the drawing channel 2 and the air vent passage 25.

Such a sample analysis device comprising laminated films can beproduced, for example, by laminating films 11, 12, 13 and 14 which areformed into various shapes with the reagent film 7 and the hydrophobicporous film 8 therebetween as shown in FIG. 2.

The film 14 is prepared to form the back side of the sample analysisdevice, and the window 10 is formed therein. In the film 13, cut-outportions for forming the liquid pooling portion 9, the air vent passage25, the analysis section 3 and the drawing channel 2 are formed. Thefilm 12 is prepared to ensure the thickness of the liquid poolingportion 9 (the size of the cross section of the passage), and a cut-outportion for forming the liquid pooling portion 9, a circular cut-outportion for making the end of the air vent channel 25 open, and acircular cut-out portion for leading the drawing channel 2 b to thesuction generating chamber 1 are formed in the film. In the film 11, anapproximately cylindrical convex portion for forming the suctiongenerating chamber 1 is formed as a protrusion, and a circular cut-outportion for making the end of the air vent passage 25 open is alsoformed.

Then, the reagent film 7 is placed between the film 14 and the film 13in a position to form the analysis section 3, and the hydrophobic porousfilm 8 is placed between the film 13 and the film 12 in a position to bea certain place in the drawing channel 2 b, and in this state, the fourfilms 14, 13, 12 and 11 are laminated in this order from the bottom andintegrated together, so that the sample analysis device shown in FIG. 1can be produced.

An example of the above-mentioned hydrophobic porous film is hydrophobicresin porous film, and particular examples are polyethylene porous film,polypropylene porous film, polytetrafluoroethylene (PTFE) porous film,and the like. Examples of suitable hydrophobic resin porous film in thepresent invention include Celgard (product name; produced by HoechstCelanese Co., Ltd.), and Hipore (product name; produced by AsahiChemical Industry Co., Ltd.). The average diameter of the pores in thehydrophobic resin porous film is usually from 0.1 to 1 μm, preferablyfrom 0.3 to 0.7 μm. Furthermore, the thickness of the hydrophobic resinporous film is usually from 10 to 100 μm. Such a hydrophobic resinporous film can be produced, for example, by forming a film using saidhydrophobic resin and then orienting the film either uniaxially orbiaxially.

The reagent film 7 is prepared by impregnating a film with a reagent,and the type of the reagent is selected as appropriate depending on thetype of the object to be analyzed. The structure of the reagent film isalso determined as appropriate depending on the type of the object foranalysis. For example, when plasma components of blood are to beanalyzed, the reagent film used usually comprises a filtration layer forseparating erythrocytes, a reagent layer impregnated with a reagent, anda base material, which are laminated in this order. Then, the reagentfilm 7 is arranged in the analysis section 3 in such a manner that thefiltration layer can contact with blood (a liquid sample). Furthermore,conventionally known materials can be used for the respective layers inthe reagent film.

When the sample analysis device is produced, the films may be integratedtogether by bonding the films to each other with an adhesive, or bylaminating by pressing or heating.

Furthermore, examples of the materials for the films constituting thesample analysis device include polyethylene, polyethylene terephthalate(PET), polystyrene, polyvinyl chloride, and the like. Among theseexamples, PET is preferably used because of its good processibility.

The dimensions of the sample analysis device shown in FIG. 1 are asfollows. The overall size of the device is usually 15 to 60 mm inlength, 5 to 20 mm in width and 1 to 3 mm in thickness. Furthermore, thesize of the suction generating chamber 1 is usually 3 to 15 mm indiameter and 0.5 to 3 mm in height. The size of the drawing channel 2 isusually 10 to 40 mm in overall length, 0.5 to 2 mm in width and 0.1 to0.5 mm in thickness; and usually, the drawing channel 2 a is 5 to 30 mmin length, and the drawing channel 2 b is 5 to 30 mm in length.Furthermore, the size of the analysis section 3 is usually 2 to 10 mm indiameter and 0.1 to 1 mm in height. The size of the liquid poolingsection 9 is usually 2 to 10 mm in length, 2 to 10 mm in width, and 0.2to 1 mm in thickness. The size of the air vent passage 25 is usually 2to 10 mm in overall length, 0.5 to 2 mm in width and 0.1 to 0.5 mm inthickness; and the opening thereof is usually 0.5 to 5 mm in diameter.The size of the suction opening 4 is usually 2 to 10 mm in width and 0.2to 1 mm in thickness.

Next, an example of an embodiment of a suction generating deviceaccording to the present invention for developing suction in the suctiongenerating chamber 1 of the above sample analysis device will beillustrated referring to FIGS. 3 and 4.

FIG. 3 is an exploded perspective view of the above-mentioned device. Asshown in the drawing, this device comprises four parts, namely, a coverplate 61, a middle plate 62, a bottom plate 63 and an operation plate64. A protruding portion 642 for compressing the suction generatingchamber is formed in an approximately center portion on the lower sideof the operation plate 64, and a protruding portion 641 (a finger grip)for operation is formed in an approximately center portion on the upperside of the operation plate 64. A cavity 631 for inserting the sampleanalysis device therein is formed in an approximately center portion inthe bottom plate 63, and a hole 632 for light irradiation is punched ina determined portion in the cavity 631. The hole 632 is formed in aposition that will correspond to the analysis section 3 when the sampleanalysis device is inserted into the cavity. A concave portion 623 forfitting the operation plate 64 therein is formed in the middle plate 62,and a window section 621 is formed in the center portion of the concaveportion 623 to let the lower protruding portion 642 on the operationplate 64 protrude therethrough. Furthermore, an open section 622 forplacing a detector such as an optical sensor is formed in the middleplate 62. A window section 611 is formed in the cover plate 61 to letthe upper protruding portion 641 on the operation plate 64 protrudetherethrough.

The dimensions of this device are determined as appropriate depending onthe size of the sample analysis device used. For example, when it isapplied to the above-mentioned sample analysis device, the dimensionsare as follows: First, the size of the bottom plate 63 is usually 2 to10 mm in thickness; the cavity 631 is usually 5 to 20 mm in width, 1 to5 mm in depth and 20 to 60 mm in length; and the size of the hole 632 isusually 2 to 10 mm in diameter. The size of the operation plate 64 isusually 15 to 50 mm in length, 5 to 20 mm in width and 1 to 10 mm inthickness; and usually, the upper protruding portion 641 is 2 to 5 mm inheight, and the lower protruding portion 642 is 1 to 5 mm in height. Thesize of the middle plate 62 is usually 20 to 60 mm in length, 20 to 60mm in width and 1 to 5 mm in thickness; the size of the concave portionfor positioning the operation plate 64 is usually 20 to 70 mm in lengthand 5 to 20 mm in width; the size of the window section 621 formed inthe concave portion is usually 10 to 30 mm in length and 3 to 10 mm inwidth. The size of the cover plate 61 is usually 20 to 60 mm in length,20 to 60 mm in width and 1 to 5 mm in thickness; and the size of thewindow section 611 for letting the upper protruding portion 641 on theoperation plate 64 protrude therethrough is usually 10 to 30 mm inlength and 3 to 10 mm in width.

The materials for forming this device are not particularly limited, andfor example, the operation plate 64 is made of metals such as aluminum,iron, brass, or the like. Examples of the materials used for formingother parts include acrylonitrile-styrene-butadiene copolymer (ABSresin), polyacetal resin, acrylic resin, vinyl chloride resin, and thelike.

FIG. 4 shows the assembly of this device, in which the sample analysisdevice (for reference, see FIG. 1) is inserted. FIG. 4 (A) is a planview of the device, and FIG. 4 (B) is a cross-sectional view taken alongthe line I—I of FIG. 4 (A). In FIG. 4, the same parts are designated bythe same signs as in FIG. 1 and FIG. 3. Furthermore, 643 refers to awire type spring for positioning the lower protruding portion 642 formedon the operation plate 64 continuously in the center of the cavity. Inthis device, as shown by the cross-sectional view in FIG. 4 (B), whenthe sample analysis device is inserted into the cavity 631, the suctiongenerating chamber 1 is compressed with the protruding portion 642.Furthermore, as shown in FIG. 4 (A), the operation plate 64 is capableof sliding in vertical direction relative to the cavity 631 (i.e.upwards or downwards direction as shown with the arrows in the drawing),so that the lower protruding portion 642 can be moved.

Next, sampling and analyzing a sample using the above device and thesample analysis device (for reference, see FIG. 1) will be describedreferring to FIGS. 4 and 5. Also, in FIG. 5, the same parts aredesignated with the same signs as in FIG. 1.

As shown in FIG. 4 (B), as the sample analysis device is inserted andset in the cavity 631 of this device, the suction generating chamber 1is compressed with the lower protruding portion 642. In this state, thesuction opening 4 of the sample analysis device is brought into contactwith a sample 15. Then, as shown in FIG. 5(A), the sample 15 is drawninto the opening 4 by capillarity developed by the air vent passage 25and held in the liquid pooling portion 9. Furthermore, as shown in FIG.4(A), if the operation plate 64 is slid in either direction as shown bythe arrows, the lower protruding portion 642 is moved, so that thesuction generating chamber 1 is released from compression. As a result,suction is developed as the suction generating chamber 1 returns to itsoriginal shape, and as shown in FIG. 5 (B), the sample 15 held in theliquid pooling portion 9 is introduced into the analysis section 3through the drawing channel 2 a by the suction. The introduction of thesample into the analysis section 3 occurs within a very short period oftime compared to introduction by capillarity, and moreover, it is hardlyaffected by the properties of the sample such as viscosity. Furthermore,in this drawing process, because the relative liquid flow resistance inthe liquid pooling portion 9 and the air vent passage 25 is adjusted asdescribed above, a part of the sample 15 remains in the air vent passage25 as shown in the drawing, so that inclusion of air can be prevented.Furthermore, even if excess suction is developed, because thegas-permeable liquid-impermeable stopper 8 is formed, the sample 15cannot flow into the suction generating chamber 1, so that introductionof the sample into the analysis section 3 is ensured. Furthermore, inthe analysis section 3, reaction occurs between the sample 15 and thereagent in the reagent film 7 to generate a pigment, which develops acolor in the reagent film 7. Then, light is irradiated through thewindow 10 in the lower surface of the sample analysis device, and incase of the above-mentioned densitometry, reflected light is detected atthe detecting section and the degree of the color is measured.Furthermore, in this measurement, if the whole analysis section 3 istransparent and the reagent film 7 is also transparent, analysis can beperformed with transmitted light as well. Furthermore, as the sampleanalysis device is pulled out of the device, the operation plate 64 isautomatically returned to its original position by the wire type spring643.

EXAMPLE 2

Next, FIG. 6 shows a cross-sectional view illustrating an example of asample analysis device, in which an air vent hole is formed in thesuction generating chamber.

As shown in FIG. 6, the sample analysis device has the same structure asthe sample analysis device described in Example 1 shown in FIG. 1,except that an air vent hole 1 a is formed in the device. Therefore, thesame parts are designated with the same reference numerals. The size ofthe air vent hole 1 a is usually in the range of 0.1 to 5 mm indiameter.

Next, FIG. 7 shows cross-sectional views illustrating an example of thestructure of a second embodiment of the present invention which is usedwith the sample analysis device, and an example of its use.

As shown in the drawing, the device has a cavity 66, and two protrudingportions 67 a and 67 b formed in certain positions inside the cavity.The size of the device varies depending on the type of the sampleanalysis device used. For example, when it is applied to the sampleanalysis device shown in FIG. 6, the size of the cavity 66 is usually 20to 60 mm in length, 2 to 10 mm in height and 5 to 20 mm in width; andusually, the protruding portion 67 a is 0.5 to 9 mm in height, and theprotruding portion 67 b is 0.5 to 9 mm in height. Furthermore, thematerials for forming the device are the same as mentioned above.

The device is used, for example, as follows: First, the suction opening4 of the sample analysis device is brought into contact with a sample15, and the sample 15 is held in the liquid pooling portion 9. Then, ina first stage of insertion, the sample analysis device is inserted intothe cavity 66 as shown in FIG. 7(B) so that the suction generatingchamber is compressed by the protruding portion 67 a. During this stage,because the air contained in the suction generating chamber 1 escapesfrom the air vent hole 1 a, the sample is not discharged from theopening 4 by the pressure of the air from the suction generating chamber1. Then, in a second stage of insertion, the sample analysis device isinserted deeper into the cavity 66 so that the chamber is released fromthe compression by the protruding portion 67 a (FIG. 7 (C)), while theair vent hole 1 a is closed with the protruding portion 67 b (FIG. 7(D)). During this stage, suction is developed as the compressed suctiongenerating chamber is released to return to its original shape, therebymoving the sample 15 through the drawing channel 2 and into the analysissection 3 (FIG. 7 (D)). Even if the air vent is closed (FIG. 7 (C)), thesuction force that is developed in the suction generating chamberdisplays its effect in the drawing channel, thereby drawing the samplethrough the channel. The subsequent operation is the same as describedabove. Furthermore, the two-stage process of the insertion of the sampleanalysis device into the cavity of this suction generating device can becarried out either in one step or in two steps. If the sample analysisdevice is inserted in two steps, the process becomes as follows: In thefirst step, the insertion is continued until the suction generatingchamber is compressed, and then it is stopped for a while, and in thisstate, the opening is brought into contact with a sample so that thesample is drawn into the liquid pooling portion by capillarity and isheld therein, and then, in the second step, the device is inserteddeeper into the cavity and suction is generated, thereby transferringthe sample into the analysis section.

EXAMPLE 3

Next, a further embodiment of a device according to the presentinvention will be described. First, an example of the sample analysisdevice for use with this device is shown in cross-sectional view in FIG.8.

As shown in FIG. 8, the sample analysis device is the same as the deviceshown in FIG. 1 except that it has a suction generating tube 21 in placeof a suction generating chamber, so that the same parts are designatedby the same reference numerals. The suction generating tube 21 can beformed, for example, by positioning a resin sheet, which is bent in amanner so that its cross section in the longitudinal direction becomesan approximately reverse U-shape, on the body of the sample analysisdevice. In this case, one end of the suction generating tubecommunicates with the drawing channel 2 through the gas-permeableliquid-impermeable stopper 8, and the other end of the tube is open(opening 21 a). The size of the suction generating tube is usually asfollows: The thickness of the sheet is in the range of 0.01 to 2 mm, theheight inside the tube is in the range of 0.5 to 5 mm, the width insidethe tube is in the range of 1 to 10 mm, and the length of the tube is inthe range of 5 to 30 mm. The suction generating tube 21 is preferablyformed in such a manner that it does not overlap with the drawingchannel 2, the analysis section 3, or the like. This is because, inorder to develop suction in suction generating tube 21, it is requiredto draw the tube through by pressing. However, this pressing might causedeformation of the drawing channel, or the like. Examples of thematerials for forming the resin sheet include soft vinyl chloride resin,soft silicon resin, natural rubber, and the like. Furthermore, the shapeof the cross section of the suction generating tube in the longitudinaldirection is not limited to the reverse U-shape, and for example, it maybe rectangular, or the like.

Next, examples of the structure and use of this device with the sampleanalysis device are shown in the cross-sectional views in FIG. 9.

As shown in the drawings, the device has a cavity 68 b, and a protrudingportion 68 a formed near the opening of the cavity 68 b. The size of thedevice varies depending on the type of the sample analysis device used.For example, if it is applied to the sample analysis device shown inFIG. 8, the size of the cavity 68 b is usually 20 to 60 mm in length, 2to 10 mm in height, and 5 to 20 mm in width; and the protruding portion68 a is usually 0.5 to 9 mm in height. Furthermore, the materials forforming the device are the same as mentioned above.

This device is used, for example, as follows: First, the suction opening4 of the sample analysis device is brought into contact with a sample15, and the sample 15 is held in the liquid pooling portion 9. Then, asshown in FIG. 9(B), as the sample analysis device is inserted into thecavity 68 b, the suction generating tube 21 is pressed in the portion incommunication with the drawing channel 2. Then, as shown in FIGS. 9 (B),(C) and (D) in order, as the sample analysis device is inserted deeperinto the cavity, the suction generating tube 21 is sequentially deformedby the protruding portion 68 a to develop suction, and the sample 15 isthereby moved through the drawing channel 2 and introduced into theanalysis section 3. The subsequent analysis operation is the same as inthe above-mentioned Examples.

Finally, it is understood that the invention may be embodied in otherspecific forms without departing from the spirit or essentialcharacteristics thereof. The embodiments disclosed in this applicationare to be considered in all respects as illustrative and notrestrictive, so that the scope of the invention being indicated by theappended claims rather than by the foregoing description, and allchanges which come within the meaning and range of equivalency of theclaims are intended to be embraced therein.

1. A device for collecting a sample for analysis, comprising: a mainbody dimensioned to be manipulated by hand, the device having at leastone dimension selected from the group consisting of a length of 15–100mm, a width of 20–50 mm, a width of 5–20 mm and a thickness of 1–5 mm; asuction pressure generator; a drawing channel formed in the main body incommunication with the suction pressure generator, an opening in themain body being formed at the end of said drawing channel distal withrespect to said suction pressure generator; and an analytical sectionformed in said drawing channel between the suction generator and theopening, the analytical section communicating directly with the exteriorof the device through the drawing channel; and a pair of electrodescomprising a working electrode and a counter electrode provided in theanalytical section, wherein in use a sample is drawn into the main bodythrough the opening by suction pressure developed by said suctionpressure generator, and then the sample is transferred by the suctionpressure through the drawing channel into the analytical section.
 2. Adevice for collecting a sample for analysis, comprising: a main bodydimensioned to be manipulated by hand, the device having at least onedimension selected from the group consisting of a length of 15–100 mm, awidth of 20–50 mm, a width of 5–20 mm and a thickness of 1–5 mm; asuction pressure generator; a drawing channel formed in the main body incommunication with the suction pressure generator, an opening in themain body being formed at the end of said drawing channel distal withrespect to said suction pressure generator; an analytical section formedin said drawing channel between the suction generator and the opening,the analytical section communicating directly with the exterior of thedevice through the drawing channel; and a liquid pooling portion formedbetween the opening and the drawing channel, and an air vent passagebranching from a portion of the drawing channel between the liquidpooling portion and the analytical section, the end of the air ventpassage opening to the outside, wherein in use a sample is drawn intothe main body through the opening by suction pressure developed by saidsuction pressure generator, and then the sample is transferred by thesuction pressure through the drawing channel into the analyticalsection.
 3. A device as claimed in claim 2, wherein the opening has ashape enlarging toward the end.
 4. A device as claimed in claim 2,wherein the liquid flow resistance in the air vent passage is largerthan the liquid flow resistance in the liquid pooling portion.
 5. Adevice as claimed in claim 2, wherein the analytical section formed inthe drawing channel serves as a reagent positioning section and areagent reaction section.
 6. A device as claimed in claim 2, wherein areagent positioning section, a reagent reaction section and ananalytical section are provided independently in certain positions inthe drawing channel.
 7. A device as claimed in claim 6, wherein aplurality of reagent positioning sections are provided in certainpositions in the drawing channel.
 8. A device as claimed in claim 2,wherein the suction pressure generator is a suction pressure generatingchamber capable of changing its volume.
 9. A device as claimed in claim8, wherein a vent is formed in the suction pressure generating chamber.10. A device as claimed in claim 2, wherein the suction pressuregenerator is a suction pressure generating tube.
 11. A device as claimedin claim 2, wherein the drawing channel is divided into a plurality ofdrawing channel members at a position between the opening and thesuction pressure generator, each of the drawing channel members beingprovided with an analytical section and being in communication with thesuction pressure generator.
 12. A device as claimed in claim 2, whereinthe drawing channel is divided into a plurality of drawing channelmembers at a position between the opening and the suction pressuregenerator.
 13. A device as claimed in claim 2, wherein the suctionpressure generator comprises a chamber formed in the main body incommunication with the drawing channel.
 14. A device as claimed in claim2, wherein the device is designed to be discarded after a single use.15. A device as claimed in claim 2, wherein a positive pressure can begenerated to return a sample withdrawn from the analytical section tothe analytical section.
 16. A device as claimed in claim 2, wherein theanalytical section is wider than the drawing channel and the drawingchannel extends from the analytical section to the suction pressuregenerator.
 17. A device for collecting a sample for analysis,comprising: a main body dimensioned to be manipulated by hand; a suctionpressure generator comprising a chamber formed in the main body; adrawing channel formed in the main body in communication with thechamber of the suction pressure generator, an opening in the main bodybeing formed at the end of said drawing channel distal with respect tosaid suction pressure generator; and a flexible cover on the main body,whereby changes in pressure in the chamber of the suction pressuregenerator are created by movement of the flexible cover, the drawingchannel being divided into a plurality of drawing channel members at aposition between the opening and the suction pressure generator, each ofthe drawing channel members being provided with an analytical sectionand being in communication with the suction pressure generator, eachanalytical section being formed in said drawing channel between thesuction generator and the opening, each analytical section communicatingdirectly with the exterior of the device through the drawing channel,wherein in use a sample is drawn into the main body through the openingby suction pressure developed by said suction pressure generator, andthen the sample is transferred by the suction pressure through thedrawing channel into the analytical section.
 18. A device as claimed inclaim 17, wherein the device is designed to be discarded after a singleuse.
 19. A device as claimed in claim 17, wherein a positive pressurecan be generated to return a sample withdrawn from the analyticalsection to the analytical section.
 20. A device as claimed in claim 17,wherein the opening has a shape enlarging toward the end.
 21. A deviceas claimed in claim 17, wherein a liquid pooling portion is formedbetween the opening and the drawing channel, and an air vent passagebranches from a portion of the drawing channel between the liquidpooling portion and the analytical section, the end of the air ventpassage opening to the outside.
 22. A device as claimed in claim 21,wherein the liquid flow resistance in the air vent passage is largerthan the liquid flow resistance in the liquid pooling portion.
 23. Adevice as claimed in claim 17, wherein the analytical section formed inthe drawing channel serves as a reagent positioning section and areagent reaction section.
 24. A device as claimed in claim 17, wherein areagent positioning section, a reagent reaction section and ananalytical section are provided independently in certain positions inthe drawing channel.
 25. A device as claimed in claim 24, wherein aplurality of reagent positioning sections are provided in certainpositions in the drawing channel.
 26. A device as claimed in claim 17,wherein a pair of electrodes comprising a working electrode and acounter electrode is provided in at least one analytical section.
 27. Adevice as claimed in claim 17, wherein a concave portion with acylindrical inner shape is formed in the main body as the chamber of thesuction pressure generator and the flexible cover is disposed over theconcave portion.
 28. A device as claimed in claim 17, wherein theanalytical section is wider than the drawing channel and the drawingchannel extends from the analytical section to the suction pressuregenerator.
 29. A device for collecting a sample for analysis,comprising: a main body dimensioned to be manipulated by hand; a suctionpressure generator comprising a chamber formed in the main body; adrawing channel formed in the main body in communication with thechamber of the suction pressure generator, an opening in the main bodybeing formed at the end of said drawing channel distal with respect tosaid suction pressure generator; a flexible cover on the main body,whereby changes in pressure in the chamber of the suction pressuregenerator are created by movement of the flexible cover; an analyticalsection formed in said drawing channel between the suction generator andthe opening, the analytical section communicating directly with theexterior of the device through the drawing channel; and a pair ofelectrodes comprising a working electrode and a counter electrodeprovided in the analytical section, wherein in use a sample is drawninto the main body through the opening by suction pressure developed bysaid suction pressure generator, and then the sample is transferred bythe suction pressure through the drawing channel into the analyticalsection.
 30. A device as claimed in claim 29, wherein the device isdesigned to be discarded after a single use.
 31. A device as claimed inclaim 29, wherein a positive pressure can be generated to return asample withdrawn from the analytical section to the analytical section.32. A device as claimed in claim 29, wherein the opening has a shapeenlarging toward the end.
 33. A device as claimed in claim 29, wherein aliquid pooling portion is formed between the opening and the drawingchannel, and an air vent passage branches from a portion of the drawingchannel between the liquid pooling portion and the analytical section,the end of the air vent passage opening to the outside.
 34. A device asclaimed in claim 33, wherein the liquid flow resistance in the air ventpassage is larger than the liquid flow resistance in the liquid poolingportion.
 35. A device as claimed in claim 29, wherein the analyticalsection formed in the drawing channel serves as a reagent positioningsection and a reagent reaction section.
 36. A device as claimed in claim29, wherein a reagent positioning section, a reagent reaction sectionand an analytical section are provided independently in certainpositions in the drawing channel.
 37. A device as claimed in claim 36,wherein a plurality of reagent positioning sections are provided incertain positions in the drawing channel.
 38. A device as claimed inclaim 29, wherein a concave portion with a cylindrical inner shape isformed in the main body as the chamber of the suction pressure generatorand the flexible cover is disposed over the concave portion.
 39. Adevice as claimed in claim 29, wherein the analytical section is widerthan the drawing channel and the drawing channel extends from theanalytical section to the suction pressure generator.